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The Effectiveness of Enough Steroids as Inducement Therapy in Minimal Change Disease-like IgA Nephropathy

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ClinicalTrials.gov Identifier: NCT01451710
Recruitment Status : Completed
First Posted : October 14, 2011
Last Update Posted : July 10, 2012
Sponsor:
Information provided by (Responsible Party):
Zhi-Hong Liu, M.D., Nanjing University School of Medicine

October 7, 2011
October 14, 2011
July 10, 2012
March 2011
May 2012   (Final data collection date for primary outcome measure)
24h urinary protein excretion [ Time Frame: 3 months ]
Same as current
Complete list of historical versions of study NCT01451710 on ClinicalTrials.gov Archive Site
remission rate [ Time Frame: 3 months ]
Same as current
Not Provided
Not Provided
 
The Effectiveness of Enough Steroids as Inducement Therapy in Minimal Change Disease-like IgA Nephropathy
The Effectiveness of Enough Steroids as Inducement Therapy in Minimal Change Disease-like IgA Nephropathy
This is a single center,prospective,no-controlled clinical trial
  1. The complete remission of enough steroids as inducement therapy in adult minimal change disease-like IgA nephropathy patients
  2. The safety of enough steroids as inducement therapy in adult minimal change disease-like IgA nephropathy patients
Interventional
Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
IgA Nephropathy
Drug: Prednisone or Prednisolone
daily single dose of 1mg/kg (maximum 80mg) or alternate day single dose of 2mg/kg (maximum 120mg),maintained for a minimum period of 6 weeks and maximum period of 12 weeks. After achieving complete remission., corticosteroids should be tapered slowly, 10mg every two weeks tapered to reach 0.15mg/kg/d, then 2.5mg every two to four weeks tapered to reach the minimum dosage 10mg/ alternate day
Other Name: Prednisone, prednisolone, corticosteroids
Experimental: Prednisone or Prednisolone
Intervention: Drug: Prednisone or Prednisolone
Wang J, Juan C, Huang Q, Zeng C, Liu Z. Corticosteroid therapy in IgA nephropathy with minimal change-like lesions: a single-centre cohort study. Nephrol Dial Transplant. 2013 Sep;28(9):2339-45. doi: 10.1093/ndt/gft211. Epub 2013 Jun 19.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
Same as current
May 2012
May 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Female or male patients aged between 18 to 65 years
  • Renal biopsy was used to diagnose IgA nephropathy
  • Patients with 24h proteinuria 3.5g and serum albumin concentration lower than 30g/L

Exclusion Criteria:

  • Patients with serum creatinine ≥ 3 mg/dl or eGFR < 30ml/min per 1.73 m2
  • urine RBC > 1 million/ml
  • Patients who have received treatment of enough steroids for more than 12 weeks
  • patients with secondary IgA
  • Patients who have impaired liver function,with ALT/GPT or AST/GOT twice more than the normal upper limit or who have active hepatitis
  • Patients with 2 type diabetes or obesity, whose BMI is more than 28kg/m2
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT01451710
NJCT-1102
Yes
Not Provided
Not Provided
Zhi-Hong Liu, M.D., Nanjing University School of Medicine
Nanjing University School of Medicine
Not Provided
Study Director: Zhihong Liu, MD Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine
Nanjing University School of Medicine
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP